Cooler heads on safety
Judging from what happened at two Senate hearings last week - and more importantly what didn't happen - it seems that the congressional and media frenzy over drug safety has abated. Importantly, the suspension of sales of Tysabri natalizumab from Biogen Idec Inc. and partner Elan Corp. plc after two patients were diagnosed with progressive multifocal leukoencephalopathy didn't bring on a new attack on the industry.
Indeed, it now appears that legislation giving FDA some additional authority will be enacted, but rather than attempting to "fix" FDA by decoupling safety and efficacy oversight, it will likely seek to augment the agency's ability to conduct post-market safety evaluations and may give it more power to compel sponsors to conduct post-market trials. ...